13 results
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52ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAIRE Diagnostics
FDA UDI
Caire Diagnostics Inc.·00860008017918·Package contains:
Fenom Pro Device - P/N 900-00...
CAIRE Diagnostics
FDA UDI
Caire Diagnostics Inc.·00860008017932·Package contains:
Fenom Pro Device - P/N 900-00...
CAIRE Diagnostics
FDA UDI
Caire Diagnostics Inc.·00860008017956·Box of 50 Fenom Pro Mouthpieces, PN 810-0006
So...
CAIRE Diagnostics
FDA UDI
Caire Diagnostics Inc.·00860008017901·Package contains:
External Power Supply, P/N 19...
CAIRE Diagnostics
FDA UDI
Caire Diagnostics Inc.·00860008017949·Package contains:
Fenom Pro Device - P/N 900-00...
CAIRE Diagnostics
FDA UDI
Caire Diagnostics Inc.·00860008017925·Package contains:
Fenom Pro Device - P/N 900-00...
EQUINOX
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·April 24, 2020
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
FDA Recall
Terminated
·CAIRE DIAGNOSTICS INC·Product code MXA·February 26, 2021
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
FDA Enforcement
Class II
·Terminated·CAIRE DIAGNOSTICS INC·March 31, 2021
EIA Test Kit
FDA UDI
CRITICAL CARE DIAGNOSTICS, INC.·00867556000188·
Presage ST2 Assay Kit
FDA UDI
CRITICAL CARE DIAGNOSTICS, INC.·00867556000195·
EIA Test Kit
FDA UDI
CRITICAL CARE DIAGNOSTICS, INC.·00867556000157·
PRESAGE ST2 Controls Kit
FDA UDI
CRITICAL CARE DIAGNOSTICS, INC.·00867556000171·